Director, Regulatory CMC
Genetix BiotherapeuticsSomerville, Massachusetts, United States · Posted 2 months agoDescription
About Genetix Biotherapeutics
At Genetix Biotherapeutics every role has meaning, every team member is respected, and every day is a chance to make a difference. When you join Genetix, you're not just landing a new role, you become part of a company that's pursuing curative gene therapies to give patients and their families more days. We are doers, thinkers and collaborators who embrace and live by our values:
Our innovation is rooted in the diversity of our teams and results are achieved through cooperation and the integration of multiple viewpoints. This is personal and we approach every challenge with radical care.
The Director, Regulatory CMC is responsible for leading execution of global CMC regulatory strategies for approved and late-stage gene therapy products, with a primary focus on lifecycle management, change management, and regulatory compliance. This role supports the development and delivery of post-approval regulatory strategies and ensures effective implementation of manufacturing, analytical, and control changes across global markets.
The Director partners closely with Technical Operations, Quality, and Supply Chain to ensure alignment between regulatory requirements and operational execution. This individual contributes to regulatory interactions with health authorities and plays a key role in supporting post-approval submissions, inspection readiness, and ongoing compliance activities.
This is a full-time hybrid position (3 days a week) in our Somerville, Massachusetts office.
Specific Job Duties
- Lead execution of post-approval CMC lifecycle management activities, including preparation and submission of global supplements, variations, and annual reports
- Support development and implementation of CMC change management strategies, assessing manufacturing, analytical, raw material, facility, and control changes and recommending appropriate regulatory pathways
- Manage regulatory CMC activities supporting commercial manufacturing, supply continuity, and inspection readiness, including drafting responses to health authority questions and commitments
- Contribute to regulatory interactions with global health authorities (e.g., FDA, EMA), including support for meetings, information requests, and inspection activities
- Partner with Technical Operations, Quality, Supply Chain, and Program Teams to ensure regulatory strategy aligns with operational plans and timelines
- Author and review post-approval CMC documentation, ensuring consistency with approved dossiers and global regulatory requirements
- Ensure adherence to global CMC regulatory standards and guidance (FDA, EMA, ICH) applicable to commercial and post-approval gene therapy products
- Monitor and apply regulatory intelligence related to post-approval expectations, emerging guidance, and inspection trends
- Provide mentorship and guidance to junior Regulatory CMC team members as appropriate
- Represent Regulatory CMC on cross-functional teams and provide clear, risk-based regulatory input to support decision-making
Required Education, Experience, or Qualifications
- Bachelor’s or Master’s degree in life sciences (biochemistry, chemistry, biology, biochemical engineering, or related field)
- Minimum of 10–12 years of biopharmaceutical industry experience, with relevant experience in CMC regulatory affairs for biologics or gene therapy products
- Experience supporting post-approval CMC submissions (e.g., supplements, variations, annual reports) and regulatory interactions
- Strong understanding of commercial manufacturing and lifecycle management for complex biologics and/or gene therapy products
- Solid knowledge of GMP, CMC regulatory requirements, and global regulatory frameworks (FDA, EMA, ICH)
- Strong written and verbal communication skills, with the ability to translate technical information into clear regulatory documentation
- Demonstrated ability to work effectively in cross-functional, matrixed environments
- Strong organizational skills and ability to manage multiple priorities in a fast-paced environment
Additional Information
The pay transparency range provided below is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. We may ultimately pay more or less than the posted range, and the range may be modified in the future. This role is eligible for an annual bonus and long-term incentive. Actual base salary pay will be based on several factors, including but not limited to experience, skills, relevant education/qualifications, external market, internal equity, and other job-related factors permitted by law.
Genetix’s total rewards package also provides employees with a comprehensive and competitive benefits suite to support a variety of employee needs. These benefits include comprehensive health, life and disability insurance, employer-matched 401(k) plan, lifestyle spending account, flexible time-off + paid holidays and winter holiday period, tuition reimbursement & loan repayment assistance, paid parental leave, paid onsite parking, commuter subsidy, and much more.
Genetix is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.
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